Friday, 23 June 2017

If scientists quarrel whether a vaccine caused a disease, it's left to the courts - CJEU in W and Others (C-621/15)

On June 21 the CJEU decided in the case of product liability related to a potentially defective vaccine - W and Others (C-621/15). Mr W was vaccinated against hepatitis B in the years 1998-1999 with a vaccine produced by Sanofi Pasteur. He was diagnosed with MS in November 2000, which first led to his disability from work, then needing round-the-clock care, and finally his death in October 2011. Together with his three family members he raised a claim against Sanofi Pasteur in 2006, arguing that his illness resulted from the administration of the vaccination.

Vaccinations have long been a controversial topic as the available medical research has not been able to either conclusively prove their detrimental effects to human health or to conclusively disprove them. This is at least confirmed in this case with respect to the lack of medical research establishing a relationship or lack thereof between the hepatitis B vaccination and the multiple sclerosis disease (par. 30). Article 4 of the Product Liability Directive requires the consumer to be able to prove not only the damage, and its cause but also the causal link between the two. What evidence was submitted in this case? Mr W and Others claimed that the short period between the vaccination and the appearance of first symptoms of MS should be considered, as well as the fact that there was no trace of family history of this disease. These facts "are such as to give rise to serious, specific and consistent presumptions as to the existence of a defect in the vaccine and as to there being a causal link between the injection of the vaccine and the occurrence of the multiple sclerosis." (par. 11) 

In French law, which was applicable to this case, the Cour de cassation stated previously that with regard to the defective vaccines and the liability of pharmaceutical companies for their production, the causal link could be derived from "serious, specific and consistent presumptions". So even if the medical research does not confirm a relationship between the vaccination and the occurrence of the disease, the court could establish the defect in the vaccine and the causal link between it and the damage based on, indeed, the lack of medical family history with this disease and the short time that passed between the vaccination and the occurrence of the disease (par. 13). I think it bears repeating: despite the lack of medical research evidencing this relationship.

Considering that the PLD does not specify what should be considered a sufficient proof of the causal link between the defect and the damage that the consumer needs to establish, it is left to the Member States to decide what evidence is admissible, the level of proof required and the rules for national courts how to evaluate it (par. 25). The established procedural rules should comply with the principle of effectiveness, of course (par. 26), which cannot lead, e.g., to the shift in the burden of proof pursuant to Article 4 PLD or undermine the effectiveness of the strict liability system adopted by this Directive (par. 27). The CJEU confirms that the French procedural rules do not lead to such a shift in the burden of proof but rather just alleviate it by making it easier for consumers to establish the causal link - without having to "produce, in all circumstances, certain and irrefutable evidence of a defect in the product and of a causal link between the defect and the damage suffered" (par. 28). The national court may then conclude that "such a defect has been proven to exist, on the basis of a set of evidence the seriousness, specificity and consistency of which allows it to consider, with a sufficiently high degree of probability, that such a conclusion corresponds to the reality of the situation." (par. 28). Furthermore, the possibility to ban the use of circumstantial methods in proving the causal link would be contrary to the PLD, esp. in situations like here: where the medical research is inconclusive (par. 30), as it would disallow consumers' successful claims of product liability due to excessively difficult burden of proof (par. 31). 

Generally then, the CJEU accepts a possibility that national law establishes producers' liability only on the basis of circumstantial evidence. However, it continues to observe that procedural rules may not harm producers by accepting "unjustified presumptions" (par. 34). When would this occur? For example, if national courts are overly rigorous in their application of these evidentiary rules and start accepting irrelevant or insufficient evidence, as a consequence (par. 35). The CJEU goes even further, if national court would draw an automatic presumption on the existence of the defect and of causal link, just because "one or more types of factual evidence were presented together" - this would lead to the disregard of the burden of proof as "the producer could then find itself, even before the courts ruling on the merits of the case had the opportunity to familiarise themselves with the producer’s evidence and arguments, in the position of having to rebut that presumption in order to defend itself successfully against the claim" (par. 36). Therefore, the producer's right to defense needs to be respected.

Concluding, the national court may use circumstantial evidence - if it is sufficiently serious, specific and consistent - to conclude that despite the producer's arguments and evidence presented by him "a defect in the product appears to be the most plausible explanation for the occurrence of the damage, with the result that the defect and the causal link may reasonably be considered to be established." (par. 37).

The CJEU actually addresses the facts of this particular case in the par. 41-42 of the judgment. It seems to advise the national court that in the given case it could be likely to establish a defect and causal link, considering the lack of medical family history of the disease, temporal proximity between the vaccination and the occurrence of the disease, but also the existence of a significant number of reported cases of the disease following such vaccines being administered. This could make it the most plausible explanation for the national court that the administration of the vaccine led to the disease and that the vaccine, therefore, did not offer the safety it should have. But such conclusions have to be drawn "in a fully enlightened manner in each specific case" - the producer's rebuttal being the most important evidence to the contrary.

I think this judgment may lead to quite some disputes. On the one hand, supporters of medical research may feel that the lack of conclusive evidence of the harmful effects of the vaccination should not lead to producers' liability. On the other hand, considering the difficulties consumers would have in acquiring conclusive proof based on medical research, that's contrary, of the harmful effects of the vaccine, the alleviation of the burden of proof might seem reasonable to others.

Thursday, 15 June 2017

Mediation may be mandatory but should be free to withdraw from and of lawyers - CJEU in Menini and Rampanelli (C-75/16)

Yesterday the CJEU issued also the first judgment on the new ADR Directive in the case of Menini and Rampanelli (C-75/16). We have previously commented on the AG Saugmandsgaard Øe's opinion (First case on new ADR Directive...) and the CJEU agreed with the AG's assessment that the new ADR Directive does not preclude Italy to prescribe mandatory mediation procedure, as long as parties retain the right to access the judicial system. The "voluntary nature of the mediation lies, therefore, not in the freedom of the parties to choose whether or not to use that process but in the fact that 'the parties are themselves in charge of the process and may organise it as they wish and terminate it at any time'" (par. 50). The right to access the judicial system would be guaranteed if e.g. the outcome of the ADR procedure is not binding on the parties and if the limitation periods do not expire during such a procedure (par. 56). However, as currently the Italian mediation procedure requires consumers to use legal services (which is contrary to Art. 8(b) of ADR Directive, see par. 64) and does not allow them to withdraw from the mediation process unless they demonstrate the existence of a valid reason for such a withdrawal, these features of the mediation procedure are in breach of the ADR Directive. The latter function makes ADR procedure binding to an extent (see par. 57 and 67 on the necessity of free withdrawal from the ADR procedure at any stage).

The CJEU in providing this answer left a lot of questions posed by the national court unanswered. It left it to the national court to determine whether "an application to have an order for payment set aside and an application for a stay of provision enforcement associated with that measure constitute a complaint by a consumer, of an independent nature in relation to the order for payment proceedings instituted by a trader working in credit..." (par. 42). The ADR Directive applies only if the ADR procedure has been initiated by the consumer.

CJEU in TofuTown: if it doesn't come from a cow, it can't be milk

Soy milk, soy cream, soy cheese: all these names come forward relatively frequently on European markets. According to a decision issued by the the CJEU yesterday (C-422/16, BSV v GMBH), however, all these products are currently being marketed under names that do not meet the requirements of EU law. To understand why, let us take a step back. 

In the main proceedings, a German association had sued a company producing vegetarian and vegan foodstuff claiming that it infringed German rules on unfair competition by not respecting EU food regulations. 

In particular, the company traded several vegetal products using names mainly associated with dairy products, such as "cream", "milk", and so on. The usage of these terms, however, is restricted under EU law, namely Regulation 1308/2013, to "normal mammary secretion obtained from one or more milkings" - in other words, animal products. In turn, names which designate dairy products - such as cream, butter, cheese - are in principle only to be used for products based on animal milk. A very limited set of exceptions, listing names of products traditionally using milk-related names in the Member States, is adopted by means of Commission decision 791/2010. This lists features products such as "coconut milk", "horse-radish cream" and other country-specific words - with separate sections for each language.

The defendant company, however, claimed that allowing a broader understanding of the exception, which would allow the use of diary-related words for soy and other vegetable products, would be in line with the objectives of the Regulation. According to this argument, 

"the way in which consumers understand those designations has changed massively in recent years, and that it does not use terms such as ‘butter’ or ‘cream’ in isolation, but always in association with words referring to the plant-based origin of the products concerned, for example ‘Tofu butter’ or ‘Rice Spray Cream" (para 17).

The CJEU did not really engage with the submission, rather reasoning on whether an interpretation that would not allow such a reading would itself go against the Regulation's purposes. According to the court, it would not. 

"As is clear from recitals 64 and 76 of that regulation, the objectives pursued by the provisions at issue consist, in particular, in improving the economic conditions for the production and marketing as well as the quality of such products. The application of such standards is therefore in the interest of producers, traders and consumers, to protect consumers and to maintain conditions for allowing competition. Those provisions, in so far as they provide that only the products which comply with the requirements they lay down can be designated by the term ‘milk’ and the designations reserved exclusively for milk products even if those designations are expanded upon by explanations or descriptions such as those at issue in the main proceedings, contribute to the attainment of those objectives." (para 43)

The limitations, according to the court, are necessary for a proper identification of actual milk-based products. Without such limits, both consumers and producers of milk would be harmed. The contextual use of "clarifying or descriptive terms indicating the plant origin of the product at issue" is not sufficient to circumvent the restrictive rules of the Regulation (see also para 31).

In essence, the CJEU saw no reason to investigate whether in the case at stake a risk of confusion existed, either by using an "average consumer" test or otherwise. The Court simply considered itself bound by the list detailed in the Commission's decision of 2010, especially in light of the fact that the Commission would be able to revise such decision with relatively minor troubles.

The Court also briefly considered whether major complaints could be raised against the Regulation under the principles of proportionality and equal treatment. As to proportionality, the analysis remarked that the EU legislator enjoys wide discretion in matters of agricultural markets regulation, due to the broad mandate it enjoys under the Treaty.  Concerning equal treatment, and in particular the different approach to producers of non-dairy replacements for animal products (eg veggie burgers), the Court observed that different sectors show different concerns and thus equal-treatment here cannot be invoked to require different situations to be treated equally.

Producers in several member states will now likely have to change their labelling and marketing practices, and/or massively lobby the Commission for amendments to its 2010 decision.

Tuesday, 13 June 2017

General nutrition and health principles for reduction of sugar consumption - CJEU in Dextro Energy (C-296/16 P)

In anticipation of more directly consumer law-related judgments of the CJEU (tomorrow the judgment will be given in the first case pertaining to the ADR Directive), it might be interesting to bring our readers' attention to the judgment of 8th of June in the Dextro Energy case (C-296/16 P). The CJEU dismissed the appeal against the General Court's judgment, upholding its decision. The case pertained to nutrition and health claims.

Dextro Enegry is a producer of various products made mostly of glucose, which are sold on the German and European markets. In 2011 it requested authorisation of various health claims, such as "glucose contributes to normal energy-yielding metabolism" or "glucose contributes to normal muscle function". Pursuant to Regulation No 1924/2006 health claims need to be authorised and included on the list of authorised health claims before they can be used by producers. In 2015 the Commission refused, however, to authorise these health claims as they were seen to convey "a contradictory and ambiguous message to consumers, as they encouraged the consumption of sugar, whereas national and international authorities recommended a reduction in sugar intake, on the basis of generally accepted scientific advice." (The Court confirms that a number of health claims relating to glucose cannot be authorised) The Commission's opinion was not changed in case the health claims would be used only under specific conditions or accompanied by additional warnings. Dextro Energy relied on the positive opinion of the European Food Safety Authority (EFSA) stating that there is a causal link between the consumption of glucose and normal energy-yielding metabolism. Despite the Commission not questioning the EFSA's opinion, the General Court refused to authorise these health claims, considering that other relevant and legitimate factors might have led the Commission to its decision.

The interesting finding of this case is the General Court's recognition of generally accepted nutrition and health principles, pursuant to which average consumers must reduce their sugar consumption (par. 58). Such principles stand in this case in the way of authorising the use of nutrition and health claims that even if accurate may endanger consumer health.